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Also known as DT120, lysergide tartrate, LSD D-Tartrate
MM120 · 6 trials · 5 indications
The MADRS is used to assess depression severity and to detect changes due to antidepressant treatment. The MADRS includes 10 clinician-completed items. Each of the 10 questions is scored with a range of 0-6 points. An item score of 0 indicates item not present or normal, while an item score of 6 indicates severe or continuous presence of the symptoms. The total possible score is 60, and higher scores represent a more severe condition.
The HAM-A consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
To investigate the dose-response relationship for different doses of MM120 versus placebo in change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Week 4. The HAM-A consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety: Anxious mood, Tension, Fears, Insomnia, Intellectual, Depressed mood, Somatic (muscular), Somatic (sensory), Cardiovascular symptoms, Respiratory symptoms, Gastrointestinal symptoms, Genitourinary symptoms, Autonomic symptoms, and Behavior at interview (general). The central rater assessed the extent to which the subject displayed each given criterion and gave a rating on a scale of 0-4, where 4 represents the most severe symptoms. Minimum score = 0, maximum score = 56. Scores are summed and the greater the total score, the more severe illness.
The Adult ADHD investigator symptom rating scale (AISRS) total score consists of 18 items from the original Attention-deficit/hyperactivity Disorder Rating Scale (ADHD-RS). The ADHD-RS includes 9 items that address symptoms of inattention, and 9 items that address symptoms of impulsivity and hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score corresponds to a worse severity of ADHD.
| Arm | Type | Description |
|---|---|---|
| Arm 1 - Placebo | PLACEBO_COMPARATOR | A substance that is designed to have no therapeutic value |
| Arm 2 - 50µg DT120 | SHAM_COMPARATOR | A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A) |
| Arm 3 - 100µg DT120 | EXPERIMENTAL | A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A) |
| Arm 2 - 100µg DT120 | EXPERIMENTAL | A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A) |
| Arm 1- Placebo | PLACEBO_COMPARATOR | A substance that is designed to have no therapeutic value. |
| Arm 2- 25 μg MM120 | EXPERIMENTAL | A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A). |
| Arm 3- 50 μg MM120 | EXPERIMENTAL | A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A). |
| Arm 4- 100 μg MM120 | EXPERIMENTAL | A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A). |
| Arm 5- 200 μg MM120 | EXPERIMENTAL | A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A). |
| Arm 2- MM120 | EXPERIMENTAL | A total of 26 patients will receive 20 μg of MM120 administered orally twice weekly for 6 weeks. |
| Name | Type | Description |
|---|---|---|
| Placebo | OTHER | A substance that is designed to have no therapeutic value |
| DT120 | DRUG | A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A) |
| MM120 | DRUG | A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A). |
Inclusion Criteria: 1. Diagnosis of MDD per DSM-5 2. Male or female aged 18 to 74 3. Currently experiencing a major depressive episode (MDE) of ≥8 weeks and ≤24 months duration 4. MADRS Total Score ≥26 5. CGI-S Score ≥4 Exclusion Criteria: 1. Certain psychiatric disorders (other than major depres...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Supernus Pharmaceuticals, Inc. | SUPN | 1 | PHASE3 | SPN-812 |
| Axsome Therapeutics, Inc. | AXSM | 3 | PHASE3 | Solriamfetol |
MM120 is an investigational small molecule being developed by Definium Therapeutics, Inc. (ticker DFTX) for psychiatric conditions. It is in Phase 2 clinical development for generalized anxiety disorder and attention deficit hyperactivity disorder (ADHD). MM120 has been studied in randomized, double-blind, placebo-controlled trials.
MM120 is being developed to treat generalized anxiety disorder and ADHD. Its completed Phase 2 trial NCT05407064 evaluated MM120 for anxiety symptoms, and a separate Phase 2 proof-of-concept trial, NCT05200936, studied low-dose MM120 in adults with ADHD. Both indications remain investigational.
MM120 is being developed by Definium Therapeutics, Inc., which trades under the ticker DFTX. Definium is the sponsor of the clinical program evaluating MM120 in generalized anxiety disorder and ADHD.
MM120 is in Phase 2 clinical development. Two Phase 2 trials have been completed: NCT05407064 in generalized anxiety disorder and NCT05200936 in ADHD. MM120 is investigational and has not been approved by the FDA for any indication.
MM120 has been studied in two completed Phase 2 trials. NCT05407064 was a dose-finding study of MM120 for anxiety symptoms that enrolled 198 participants in the United States. NCT05200936 was a Phase 2 proof-of-concept trial of low-dose MM120 for ADHD that enrolled 53 participants in the Netherlands and Switzerland.
MM120 is also known as LSD D-tartrate, a small molecule formulation. It is being developed by Definium Therapeutics under the MM120 name for generalized anxiety disorder and ADHD.